The author offered in this paper that in developing the guidelines for Chinese and integrated medical clinical therapy, the specialties of Chinese medicine and clinical needs should be considered, and put stress on the following key points: (1) give priorities to the diseases on which plentiful evidences and practical experiences have been achieved in researches; (2) set up the clinical issues of diseases from an integral view, with Chinese medicine syndromes subordinated to diseases; (3) in making choice of clinical questions, problems that clinicians and researchers concerned should be taken in to consideration; (4) adopt the concepts and methods of complex intervention and reflect prominently the preponderant holistic thinking of Chinese medicine; (5) intensify the cognition-centered basic research of Chinese medicine through combining "disease diagnosis" and "syndrome differentiation" to acquaint the rules of disease/syndrome transformation from the integral dynamic views; (6) use the guidance establishing process of Western medicine as reference to collect, identify, review and classify the evidences from modern literature, while for those from ancient literature, the content analyzing method should be followed; (7) make the contents of design methods perfect and put emphasis on the control and guarantee of quality.
Evidence-Based Medicine ; Guidelines as Topic ; Humans ; Integrative Medicine ; methods ; Medicine, Chinese Traditional ; methods

Combined Modality Therapy ; Humans ; Medicine, Chinese Traditional ; Practice Guidelines as Topic

OBJECTIVETo analyze the quality of scientific research design of clinical literature related with treatment of Parkinson's disease with traditional Chinese medicine, so as to objectively evaluate the therapeutic effect of TCM.

METHODSAccording to principles of evidence-based medicine, clinical epidemiology/design measurement evaluation (DME), the "Table of Systematic Evaluation of Quality and Information Collection for TCM Clinical Research Literature" were established and used to evaluate clinical control trial literature related with treatment of Parkinson's disease with TCM published during 1979 to 2000.

RESULTSThe method of randomization was not described in 66.7% of the literature. Although randomized design was declared in 33.3 %, problems or mistakes of randomized allocation still existed in them. No record about the state of dropped out or absconded cases in follow-up study and without any record of samples screening presented in all literature. There were some problems of key links concerning samples' homogeneity, outcome indexes selection, conclusion deduction and so on, which could also influence the quality and reliability of randomized controlled trials.

CONCLUSIONMethodological design of clinical research of TCM on Parkinson's disease should be strengthened.

Adult ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Medicine, Chinese Traditional ; Parkinson Disease ; drug therapy ; Phytotherapy ; Research Design

OBJECTIVETo study the center effect discrepancy in the multi-center clinical trials.

METHODSTwo groups of data collected from the multi-center clinical trials were used. Data were processed by covariance analysis and Meta-analysis.

RESULTSIn the covariance analysis, the discrepancy of the center effect values indicated statistical significance. Through Meta-analysis on fixed effect model, the discrepancy in one heterogeneity test showed no statistical significance (P > 0.05) while the inter-group discrepancy of the merged effect values drawn from analysis based on fixed effect model having statistical significance (P < 0.05). In the random effect model, the discrepancy in one heterogeneity test showed statistical significance (P < 0.05) while the inter-group discrepancy of the merged effect values drawn from analysis based on random effect model having no statistical significance (P > 0.05).

CONCLUSIONSStudies on multi-center random controlled clinical trials, when statistical significance was found in the interaction discrepancy between the inter-center and the center-group relation, the merged effect values should be compared and analyzed by an appropriate statistic model based on the heterogeneous test results from the Meta-analysis. However, if the result from covariance analysis and the one from Meta-analysis did not agree to each other, the results drawn from the Meta-analysis were reliable.

Data Collection ; Humans ; Multicenter Studies as Topic ; methods ; Randomized Controlled Trials as Topic ; methods

Objective To explore the correlation between the circuit qi endowment and the prevalence of chronic obstructive pulmonary disease(COPD)by studying the characteristics of five circuits and six qi at birth date and on the date of acute exacerbation of patients with COPD,so as to provide the traditional Chinese medicine(TCM)circuit-qi thoughts for clinical prevention and treatment of diseases.Methods An epidemiological cross-sectional study was carried out in 3 411 patients with COPD.The correlation of the prevalence of COPD with the circuit qi at birth date and on the date of acute exacerbation was retrospectively analyzed after time conversion according to the rules of five circuits and six qi in TCM.Results(1)The analysis of circuit qi at birth date showed that the dominant qi of COPD patients at birth date was predominated by yangming dry-gold,the joining of guest qi with dominant qi was predominated by taiyin damp-earth and yangming dry-gold,the three patterns of five circuits(the excess,deficiency and balanced state of yearly evolutive phase)were characterized by excess fire circuit with the maximum residual,and the comprehensive circuit qi was predominated by taizheng(excess fire circuit),shaoyang ministerial fire and jueyin wind-wood.There were statistically significant differences in the distribution of above circuit qi at birth date(P＜0.05 or P＜0.01).(2)The analysis circuit qi on the date of acute exacerbation showed that the suiyun(yearly evolutive phase)was predominated by taizheng(excess fire circuit)and shaogong(deficiency earth circuit),the sitian-zaiquan semiannual circuit qi was characterized by taiyang cold-water and taiyin damp-earth with the maximum residual;the guest qi was predominated by yangming dry-gold,the joining of guest qi with dominant qi was predominated by yangming dry-gold and shaoyin monarch fire,the three patterns of five circuits(the excess,deficiency and balanced state of yearly evolutive phase)were characterized by the balanced wood circuit with the maximum residual,and the comprehensive circuit qi was predominated by taizheng(excess fire circuit),taiyang cold-water,and taiyin damp-earth.There were statistically significant differences in the distribution of above circuit qi on the date of acute exacerbation of COPD(P＜0.05 or P＜0.01).Conclusion There is a certain correlation between the circuit qi endowment and the prevalence of COPD.The analysis of the five-circuit and six-qi characteristics of COPD patients at birth date and on the date of acute exacerbation will be helpful for the early identification of susceptible population and acute exacerbations,so as to perform early intervention and prevention before illness.